A Phase 2b, Randomized, Controlled Trial Evaluating GS 5806 in Lung Transplant (LT) Recipients with Respiratory Syncytial Virus (RSV) Infectio
- Conditions
- respiratory infectionRSV infection1004743810024970
- Registration Number
- NL-OMON43361
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
1) Males and females * 18 years of age who have received a LT (single or double) or heart/lung
transplant > 90 days prior to Screening
2) Confirmed to be RSV-positive by local polymerase chain reaction (PCR) testing (starting
from when the upper or lower respiratory tract sample is obtained) * 7 days prior to IMP
administration on Day 1/Baseline
3) New onset or acute worsening, if the symptom is chronic, of at least 1 of the following
respiratory symptoms * 7 days prior to IMP administration on Day 1/Baseline: nasal
congestion, earache, runny nose, cough, sore throat, shortness of breath, or wheezing
4) An informed consent document signed and dated by the subject
5) A negative local urine or serum pregnancy test for female subjects of childbearing potential
at Screening within 1 day prior to IMP administration. When available, existing local
pregnancy test results obtained prior to Screening may be used, provided the testing was
completed within 1 day prior to IMP administration.
6) Agreement from male and female subjects of childbearing potential who engage in
heterosexual intercourse to use protocol specified method(s) of contraception as described in
Appendix 6
7) Ability and willingness to complete necessary study procedures
1) Use of any non-marketed (according to region) investigational agents within 30 days, OR
use of any investigational monoclonal anti-RSV antibodies within 4 months or 5 half-lives of
Screening, whichever is longer, OR use of any prior investigational RSV vaccines
2) Use of a strong or moderate cytochrome P450 enzyme (CYP) inducer including but not
limited to rifampin, St. John*s Wort, carbamazepine, phenytoin, efavirenz, bosentan,
etravirine, modafinil, and nafcillin, within 2 weeks prior to the first dose of IMP
3) Use of any of the following lympholytic treatment within the stated time frame:
anti-thymocyte globulin (ATG), < 3 months; anti-lymphoblast globulin (ALG), < 3 months;
muromonab-CD3 (OKT3), < 3 months; rituximab < 6 months; alemtuzumab < 9 months
Related to transplant history:
4) Recipient of any other organ transplant prior to Screening, with the exception of a LT
(single or double) or heart/lung transplant
5) Recipient of a hematopoietic cell transplant at any time
6) Presence of BOS Stage 3 at Screening defined as a FEV1 of 50% or less of baseline
Related to medical condition at Screening:
7) Respiratory failure requiring invasive mechanical ventilation
8) Evidence of shock requiring vasopressors
9) Known viral coinfection (including but not limited to influenza, metapneumovirus, human
rhinovirus, parainfluenza, cytomegalovirus, or coronavirus) in the upper or lower respiratory
tract * 14 days prior to Screening unless discussed with the medical monitor and deemed
acceptable
10) Active systemic infection or infectious pneumonia of any etiology (ie, bacterial, viral
[other than RSV] or fungal), including aspiration pneumonia, that is considered clinically
significant by the investigator unless discussed with the medical monitor and deemed
acceptable
11) Pregnant or lactating females
12) Evidence of recent and rapidly deteriorating lung function, occurring before the onset of the
current viral respiratory infection, including but not limited to: acute lung allograft rejection,
rapidly-progressive CLAD, and rCLAD (as determined by the investigator)
13) Any condition which, in the opinion of the investigator, would prevent full participation in
this study or would interfere with the evaluation of the trial endpoints
Related to allergies:
14) Known hypersensitivity or allergy to the IMP, its metabolites, or formulation excipients
(microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl
alcohol, titanium dioxide, polyethylene glycol and talc)
15) History of hypersensitivity, anaphylactic reaction, Stevens-Johnson Syndrome, or toxic
epidermal necroylsis response to sulfa drugs
Related to laboratory values:
16) Clinically significant kidney dysfunction as defined by:
An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as calculated by the
Modification of Diet in Renal Disease (MDRD) study 4 parameter equation obtained from
screening laboratory measurements or via local laboratory measurements obtained * 7 days
prior to Screening. The eGFR may be manually calculated or the reported eGFR value may
be used, but any automatically calculated eGFR must be calculated using the MDRD
equation.
17) Clinically significant liver function test abnormalities as defined by an ALT or AST
> 5 times the ULN obtain
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The co-primary efficacy endpoints are<br /><br>* Time-weighted average change in log10 viral load from Day 1/Baseline through<br /><br>Day 7 (DAVG7) as measured in nasal samples by RT-qPCR among subjects in the FAS<br /><br>* Time-weighted average change in log10 viral load from Day 1/Baseline through<br /><br>Day 7 (DAVG7) in a subset of FAS subjects whose duration of RSV symptoms prior<br /><br>to the first dose of study medication is * median</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are:<br /><br>* Time-weighted average change in FLU-PRO score from Day 1/Baseline through Day<br /><br>7<br /><br>* Percent change from study baseline in FEV1% predicted value at Day 28/End of<br /><br>Study</p><br>